BEUDAMED
    FDA Enforcement Class II Terminated

    Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.

    Recall: Z-1062-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1062-2013
    Event ID
    64200
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    January 11, 2013
    Classification Date
    April 5, 2013
    Termination Date
    August 31, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Flexible Grip which is part of the Synthes Universal Nail System. Indicated for the conventional (non-locking) technique of treating stable diaphyseal fractures.

    Reason

    Synthes is initiating a voluntary recall of the Flexible Grip (Part number 355.28) which is part of the Universal Nail System, due to the potential lack of the ability to thoroughly clean the instrument.

    Code Info

    Part number 355.28, all lot numbers

    Distribution

    Nationwide Distribution including the states of AZ, CA, CO, FL, IA, ID, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, PA, RI, TN, TX, UT, VT, WA, WI, and WV.

    Quantity

    328